Sample ISO 9001 Internal Auditing Procedure

1. PURPOSE
The purpose of this procedure is to define the steps that follows in planning, performing, reporting, recording, and following up on internal audits.
conducts internal audits to determine whether the quality management system:
- Conforms to planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by (QMS Manual policies, procedures, work instructions, and forms)
- Is effectively implemented and maintained.

2. SCOPE
This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system.

3. DEFINITIONS
None

4. REFERENCES
4.1 Quality Manual,
5. ASSOCIATED DOCUMENTS
5.1 Audit Check List,
5.2 ERC/ERO Procedure,
5.4 Audit Schedule,
5.3 Audit Notebook

6. PROCEDURE
NOTE 1: This procedure is typically initiated about four weeks prior to the execution of an internal audit as called for by ’s audit schedule. The audit schedule is established and maintained by The Quality Assurance Manager.
NOTE 2: Every element in the quality system is audited on a regular basis and at minimum of once per year. Activities are audited more frequently if there are significant changes taking place (i.e., many new hires/high turnover of personnel, modified procedures and work instructions, etc.) or if there is a history of problems in that area.
NOTE 3: Only qualified personnel may perform internal auditing activities. These qualified personnel are classified as internal auditors and have received the following training as a minimum: 1 day training on internal auditing techniques, 1 day training on the ISO 9001 Standard, this training may be performed by previously trained internal auditors.

6.1 AUDIT PLANNING, COORDINATION, AND PREPARATION
6.1.1 The Quality Assurance Manager defines the specific criteria, scope, methods, and objectives for the upcoming internal audit based on the status, maturity, and importance of specific elements in ’s quality system.
Audits shall be carried out to a defined scope and shall be as follows,
a) Planned: as per the internal audit plan
b) Unplanned: arising as a result of,
- Customer complaints
- Following the implementation of actions defined in a corrective action report
- Following the identification of additional or amended procedures for products
NOTE 4: In planning the particular audit, these activities include determining the extent and boundaries of the audit (locations, activities, processes); set of policies, procedures and/or requirements to be audited against; auditing methods; and audit objectives.
6.1.2 The Quality Assurance Manager selects the appropriate auditor to ensure objectivity and impartiality of the audit process.
6.1.3 The Quality Assurance Manager and the auditor review the proposed audit program to ensure that it is consistent with and effective for the defined audit criteria, scope, methods, and objectives.
6.1.4 Prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited.

6.2 INTERNAL QUALITY AUDIT INVESTIGATION

6.2.1 The auditor will contact the personnel in the area being audited at the time indicated on the audit program, and briefly review the audit criteria, scope, methods and objectives with them.
NOTE 5: The checklists only serve as a guide to the auditors, and other areas may be investigated as deemed necessary by the auditors or as requested by the auditee.
6.2.2 When a nonconformance is identified, the auditor presents the nature of the nonconformity and the evidence to the personnel involved for verification, clarification, and addresses any questions or concerns that the personnel may have, as well as to give advice, when requested, regarding any problems which are uncovered.
6.2.3 If the nonconformance is confirmed, then go to step 6.2.5.
6.2.4 If the possible nonconformance requires further clarification the auditor will discuss the situation with the Quality Assurance Manager.
6.2.5 After the facts of the nonconformity are verified (or modified), the auditor either drafts nonconformance statement or documents the necessary information for writing one later.
NOTE 6: The nonconformance statement includes the nature of the nonconformity, the actual evidence obtained, and the nature of the requirement that is not being complied with (i.e., the appropriate ISO 9001 clause number, the appropriate quality system document section/page/paragraph, what the personnel says is the normal practice, contract requirements, statutory regulations, current standards, and any other relevant requirements).

6.3 REPORTING AND FOLLOW-UP
6.3.1 Within 2 weeks of completing the internal audit program, the auditor prepares a brief internal audit report and submits it to The Quality Assurance Manager for review and approval.
NOTE 7: The audit report includes the audit’s criteria, scope, methods and objectives, the names and titles of the audit team members, a summary of general observations (i.e., general degree of compliance and any significant problems encountered), all statements of nonconformities, weaknesses, and/or opportunities for improvement, and verification results for follow-up activities performed during the audit.
6.3.2 The Quality Assurance Manager reviews and approves the internal audit report, and then distributes copies of the report to senior management and the personnel of the audited areas that were directly involved in the audit.
NOTE 8: Any additional comments or observations of the Quality Assurance Manager can be attached to the report, but the auditor’s observations be will not be deleted or modified by The Quality Assurance Manager.
6.3.3 The Quality Assurance Manager request a Engineering Change Request for any nonconformity listed in the Internal Audit Report and for any weaknesses and “opportunities for improvement” identified and documented.
6.3.4 The Quality Assurance Manager updates and maintains the long-range audit schedule based upon the documented results of the audit and the planned corrective and preventive actions.
6.3.5 The Quality Manager shall maintain an audit notebook detailing all internal and external audits carried out.
- Long-range audit schedule
- Internal audit program
- Completed checklists- signed and dated by each auditor
- Audit report

7. REVIEW PROCEDURE
Any suggested improvements or modifications to this procedure are to be passed on to the Quality Assurance Manager for discussion at the next Quality Review Committee meeting.

Management Review IN ISO 9001 Standard

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Corrective and Preventive actions

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) andEngineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

ISO 9000 Training DVD

ISO 9000 Training DVD

ISO 9000 Training DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The “Introduction to ISO 9001:2008” DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, companies can play their part in preserving our natural environment for our next generation by implementing ISO 14001:2004 Standards – Environmental Management System.

So, what is ISO 14001:2004 Standards – Environmental Management System? What is the requirement of the ISO 14001 standards? What is the content of Environmental Management System? What are the steps in implementing ISO 14001:204 Standards – Environmental Management System? You will find the answers in this “ISO 14001:2004 Standards – Environmental Management System” DVD.

The “ISO 14001:2004 Standards – Environmental Management System” DVD will elaborate in details on:

1. Introduction to ISO 14001:2004 Standards – Environmental Management System.
2. The history & origin of the standards.
3. Requirement of ISO 14001:2004 Standards.
4. Contents Of ISO 14001:2004 Standards.
5. ISO 14001:2004 Implementation Steps & Checklist.

No matter how simple or complex the business, each can benefit from the implementation of a management system based on ISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organizations processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm.

In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.

ISO 14001 Essential

ISO 14001 certification deals with Environment Management System. Environmental management system of an organization can be issued by organization for the designing and implementation of an effective management system. This certification promotes the effective and efficient management in the organization. It provides various tools which are system based, cost effective, flexible and reflect the relevant information for the environment. It was originally developed to help organizations to reduce the negative aspects of the environment. With an improved environment, a company can attain better economical benefits.

There are numerous benefits which can happen like minimizing the risk of regulatory and environment liability fines, improved efficiency, reduce operating cost with minimum wastage and used resources, business with multiple locations need not register at different at every location. Most important benefits that companies have today is that more and more companies are applying these applications to get maximum benefits and to get competitive edge as well. ISO 14001 does not specify any levels of standard for environmental performance. If it is specified the levels of environmental performance then it has to be for every business unit which is not the intention for its formation. The overall objective of making ISO 14001 is to provide a framework for a holistic and strategic approach for the organizations environmental policy.

An ISO 14001 is completely voluntary and completely different concept. Its prime objective is to comply with all business legislation and continually improve the business environment performance. This application actually helps to achieve the set business targets and goals within timeframe. Two business can completely have different measures and standards but they still will be having ISO 14001 certification. An ISO consulting and training provide assistance to a business about how to get the ISO 14001 certification. They will teach you all the process to make your process standardized that complies with certification. There are various steps for the certification mentioned below:

Establishing plans, objectives and process required.
Implementation of the process.
Checking of EMS by measuring process and reporting of business.
Improving EMS further based on reporting.
Continual improvement process.

An comprehensive ISO 14001 certification is essential to bring an organization with improved long term goal achievement, a positive reputation and increasing value of a company. A good training person or registrar can make you eligible for certification and also help you to increase your company performance and reduce the costs.

Read more at http://www.e-wia.com

ISO 14001 Standards – Control Of Forms

ISO 14001:2004, element 4.4.5, instructs an organization to control documents required by the EMS and the standard. While some companies often try to justify not controlled forms, let’s find out if forms are the same as “documents” and if they also should be controlled.

Organizations use forms and tables within their environmental, quality, H&S and other management systems. Often, instead of preparing a traditional instruction or a procedure with all the sections, such as scope, purpose and process description, a simple form can provide this information. Frequently registrars issue companies non-conformities for their not controlled forms of their EMS.

Repeatedly I discuss this issue with my clients. Regularly I hear the same answer “Why do I need control a form?” Honestly, I do not understand this! Why should a form be treated differently from any other document? How would one know that we need a form if it is not referenced in our ISO 14001 management system? If forms are not managed by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision? Anyway, what is a form? A short review will help answering this question. If we have a list of directions telling us to:

1 – prepare 2-column table

2 – note your organization’s name in the first column

3 – put your business’s URL into the 2-nd column

There is no doubt; most of us would call this three-line direction a procedure or an instruction. So, if this is an instruction, it shall be controlled per ISO 14001 Standard.

Now, what if we were given a two-column table where the first column was titled “You enterprise name” and the second column “Internet address”. We were asked to complete the form. Easy to imagine, we would enter our company’s name and our URL in the table. It means that we interpreted this table as an “instruction”. If it walks like duck it is a duck! OK, most like a duck

This example demonstrate that our first three-line instruction in English (that obviously needs to be controlled), serves the same function, producing the same result, as our form. Therefore, the form as an instruction and “shall” be controlled as well.

I suspect that the confusion regarding forms used in ISO 14001 environmental management systems is based on the fact that forms serve two purposes. Blank forms are brief instructions written in tabular language. The same form, after being completed, becomes a record. Since records are not required to have a number, I presume this transposes on the source document – our blank table. Let’s remember this and treat our blank forms as instructions letting the documentation control process govern them. There are a couple of easy tests you may take when you are tempted to use a form that has not been identified:

- If you created a form for ISO 14001:2004 EMS and found it was changed, would you like to know who did it and why?

- If you revised one of your ISO 14001 forms, would you like your users use the latest revision?

- If you are in Brazil on a business trip, would you like other employees to know where to find your form in your EMS?

If you answered, “yes” at least once, your form is a definite candidate for being a part of your formal ISO 14001 documentation management system.

ISO Certification – A Standard For a Quality Business

ISO certification is accepted as the worldwide stamp of approval for business wanting to demonstrate compliance to quality systems. It is an organization working across 161 countries around the world looking to established standards for quality of materials, products, process, etc. It provided unique identification and goodwill to the organization to conduct business with any other, to deal in a global market.

The importance of ISO certification is that it provides assurance of Quality management which gives assurance to the customers. ISO Standard assessment and certification is recognized worldwide for giving your business the competitive edge, client confidence and market place leverage.

ISO provides the necessary tools to improve and unite work force of a business to increased profit margins, work efficiency, improved accuracy and customer base right through business operations. So although the process seems daunting and time consuming, the benefits of taking the time and putting the initial hard work into certification is well worth it for the long term benefit achieved. The process also includes regular internal audits of a company, to identify any nonconformity in procedures or documentation. By this it is easy catch small errors in processes or procedures before they become costly problems.

There are many ISO Companies that provides ISO Certification, Quality management, ISO standards, ISO 9001, ISO 9000, ISO 14001, ISO 27001, ISO 17025, ohsas, ohsas 18001 etc. It helps to ensure and keep the organization focus in terms of standard and quality. This is made possible in the course of certification. The organization will be given standards to work with and other training or enlightenments. The organization is to continue to follow if it must remain in the good book of the ISO. It helps in building customers trust and confidence in the company and its products. All an all ISO certification is very important for the growth and trust of customer on the business.

Integrate ISO 14001 with Existing procedures

Much of what an organization must do in an ISO 14001 EMS is probably already being done. No organization can operate without some environmental programs in place. These programs may need modification to comply with the ISO 14001 standard, but they serve as a good starting point to begin construction of an ISO compliant EMS. In fact, a good way to look at your EMS Manual is to view it as a road map. It will tell people where to find programs the organization uses to handle environmental concerns such as: wastewater systems operational manuals, air permit operating requirements, hazardous wastes handling procedures, materials purchasing requirements, and so forth.

A well-conceived ISO 14001 EMS will use existing environmental programs and procedures as a foundation. It will also include the business management practices of the company wherever possible. An example of this would be tying environmental impacts of raw materials purchases into an existing procedure to review raw materials specifications for engineering requirements and consistency. Many firms already have such procedures in place.

Other types of program integration may include integrating cost accounting practices with environmental operational practices. Many organizations cannot actually determine where their environmental dollars go. As a result, they cannot identify opportunities for financial improvement in environmental practices. Without such information, the environmental management of an organization is difficult. If management cannot see any cost benefit in environmental decision making, the managers usually take the least costly option. Activitybased costing allows a more comprehensive understanding of how environmental expenses are accrued by process and product rather than by facility or region. Then process control and product design can be reviewed to see if costs associated with their environmental impacts can be minimized. This is a good example of what ISO 14001 hopes to accomplish–good financial management leading to better environmental control.

Initial Review Of Gap Analysis In ISO 14001

A fundamental concept of the ISO 14001 EMS Standard is continual improvement of environmental performance. Before you can plan for improvement, you must first determine the current state of the organization’s environmental programs.

The initial review or gap analysis is, in itself, a microcosm of a well-organized approach to the entire ISO 14001 EMS development process. Each specification of the standard must be reviewed, including policy, legal requirements, training, objectives and targets, operational control systems, document control, auditing, management review, and corrective action.

The review should take into account the culture, products, marketing strategies, and other specifics of the organization. In all cases, consideration should be given to the full range of operating conditions, including possible incidents and emergency situations that may be encountered.

The ability of suppliers and subcontractors to comply with the Organization’s EMS program and applicable regulatory requirements should also be evaluated. It is strongly recommended that the initial review consider energy use, financial accounting, and information systems so that these issues may be integrated into the EMS program.

To effectively begin the Initial Review, several things must happen. First, Management should issue a company-wide announcement of intent and endorsement. This should include estimates of the time required to complete the Initial Review, and time required to complete the entire project. Second, the project leader should be identified and vested with ample authority for completion of the project.

The Initial Review is a review of all pertinent documents, from which an accurate plan is designed for the EMS Gap Analysis.

All information from the review, including deviation from regulatory requirements and adverse impacts on the environment, should be identified along with policies, programs, procedures, training and work instructions, and operational controls.

A portion of the project team should begin to assemble a registry of appropriate regulations identified during the Initial Review. All pertinent national, state, local and self-subscribed requirements should be assembled. They should be compared with identified environmental impacts.

An Initial Review is also important in ensuring that EMS design is compatible with all current organizational management structures and operations wherever possible. This is especially important where the EMS interfaces with the site’s existing health and safety, accounting, computer systems, purchasing, energy utilization and other management programs. The focus will be to achieve operational efficiencies that ensure environmental improvements and maximize cost reductions.

Initial Review outputs will be:

· An EMS Gap Analysis Design that details where existing environmental management procedures must be further investigated to determine conformance with the Standard.

· A review of the site’s overall environmental management strengths/weaknesses.

· A schedule of events for the Gap Analysis.

The gap analysis allows for a quick but comprehensive assessment of the facility’s existing environmental management practices and procedures, and compares them

with the requirements of the Standard. To perform the Gap Analysis, a standard template tailored for that specific purpose is used. The template is a questionnaire with a three way scoring system, which develops a final rating of the current programs of the site as they compare with the sections of the Standard. The score from this questionnaire and investigative template identifies which areas of the EMS might be enhanced to improve environmental performance and comply with the Standard.

Based on the results of the Gap Analysis, the project schedule and design may require modifications. Modification should precede further systems development. Using the results of the Gap Analysis, the EMS developmental process can now begin.

This may involve modifying existing procedures, adapting other business procedures such as those designed for health and safety, accounting, or risk management to environmental utilization. At certain points, new procedures will be required.

Prior to embarking on EMS development, always remember that the more flexible your EMS is, the easier it will be to implement and the more flexible it will be in the future.

ISO 9000 Standards Certification and Registration

The International Standards Organization is responsible for two major sets of requirements that relate to an overall quality management system to be used by businesses. The ISO 9000 family of standards is the primary set of requirements for most businesses.

Quality management by definition address that the organization does certain things to “fulfill the customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives”.
ISO 14000 address the environmental management to minimize harmful effects to the environment. Again, it is a quality management system designed to “achieve continual improvement of its environmental performance.

ISO certification 9000 is the most common. So, let’s take a look at what ISO certification entails and what it means. To become certified, a quality management system must be in place that meets the requirements of the ISO standard. This begins with the business recognizes the requirements and developing a quality system to meet their needs at the same time they meet the requirements.

ISO 9000 certification and ISO 9000 registration are two different entities, though they are often used interchangeably. To achieve ISO certification 9001 , an independent registrar is hired to audit the quality system for thoroughness and compliance to all the standards. When this is accomplished, the business is offered a certificate stating that the quality system conforms to standards within the particular standard.

ISO registration means that the certification has been recorded in its client register. Because most companies have been certified and in turn registered, the terms are offed interchanged in general use. While the term “certification” is the most widely used, “registration” used in North America. Both are completely acceptable, because the business has fulfilled the requirements set forth by ISO.

ISO 9000 Document Management Software System

Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

Why Is ISO 9001 Standards Important?

Industrialization has completely gone under a drastic change with the growling levels of development. With the advancement in technology, there is huge competition between major players. Thus, to stand up with such high competition and developments, all sectors must produce apt services and products according to the needs of the consumers.

This could be just that the quality management system intends continual development in the company beginning from the purchasing department, design, marketing, production, and various other departments in order to provide the best of services and products, which is harmless to both the consumers as well as the environment.

To maintain the quality standards, one needs to get International Organization for Standards (ISO) that symbolizes the quality management standard at international standards. For every company, which deals in facilitating any type of services and goods, it is very important to get certified from ISO 9001:2008.

ISO 9000 is a group of standards for the quality management system and is managed or administered by the certification and accreditation bodies. Few of the requirements in the ISO 9001, one of the standards from the group or family of ISO 9000 include:

A set of methods, which covers all the main and essential processes in the industry
Monitoring each and every process to make sure that it is effective
Maintaining adequate records
Checking all outputs for any kind of defects with corrective and appropriate action where required
Regularly reviewing individual procedures and quality system as well for its effectiveness
Last but not the least, facilitating continual improvement

An organization or company, which has been autonomously certified and audited to be in conformity with the ISO 9001:2008, might publicly state that it is certified with International Organization for Standards 9001:2008 or ISO 9001:2008 registered. Nevertheless, certification with ISO 9001:2008 standards does not ensure conformity and thus the quality of end services and products, to a certain extent certifies that reliable and dependable business procedures are being applied.

Besides, to get the ISO 9001:2008 certifications, one is required to accomplish various obligations of quality control. Few of the vital clauses that must be put up to avail the ISO 9001:2008 include knowledge, range, expressions, identifications, resource management, conscientiousness, analysis, product recognition and measurement. To avail the international standards for organization 9001 certificates, one can easily get them from several certificate providers.

The providers provide the certificate once they have carefully analyzed the production and various other production departments that include quality control standards. In addition, ISO 9001:2008 is offered only when the parent company is pleased and convinced with the output. Hence, for those individuals or businesses that are looking forward to seek ISO 9001:2008 certificates, they must make sure that they fulfill all the required industrial norms.

The practice of ISO 9001:2008 for successful operation and improved customer contentment shows the way to retention of the services and goods for a longer period. With the application of ISO 9001:2008, one can also experience decreased audits and improved marketing. ISO 9001:2008 assists in endorsing international deals, revenue that directs to worker enthusiasm and self-esteem inoculation of types.

For more information on ISO 9001 Standards, kindly visit http://www.iso9001store.com